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Mammography violations bring fines

The Nevada State Health Division has fined Desert Springs Hospital and Medical Center $1.14 million for more than 200 violations in its mammography department, including failing to document whether its mammogram system was operating as it should before some patient exams in 2007, health officials announced Wednesday.

Because of the violations, 92 patient records were missing, and the patients had to undergo additional screenings, the health division said.

The records in question, which Desert Springs officials said were misplaced, would have shown whether tests had been conducted to ensure the mammogram system was operating properly before the patients underwent mammograms, said Ed Sweeten, supervisor of the health division's Bureau of Health Quality and Compliance Radiological Health Section.

The section is responsible for conducting annual inspections of Nevada's 60 to 70 radiology programs. The inspections are conducted for the state and the federal Food and Drug Administration, Sweeten said.

Sweeten said the violations stemmed from an annual inspection by his department in February, although the health division was notified by Desert Springs in late January that it "had some issues" with its records.

During the inspection, inspectors documented 228 violations. They were problems in quality assurance and control and maintenance of records. Quality assurance and quality control documentation is used to verify the mammography department checks the X-ray machine, processing agents, darkroom, image quality and chemicals.

"We're not saying they didn't conduct the pretests, but they do not have the records showing proof that they did,'' Sweeten said.

State health officials said that during the inspection and after reviewing patient records, they determined the mammography department did not have documentation for its pretesting of the X-ray machine between April 30 and Sept. 21, 2007.

One of the checks involves producing an image of a "phantom" breast, a square block that mimics a breast. The test is conducted to ensure no photographic issues exist with the X-ray such as problems with density or contrast, Sweeten said.

"If the test isn't conducted and, let's say there is a speck of dust in the machine, it could impact the diagnostic interpretation of a patient's film," he said. "Something as small as a speck of dust can look like a micro-calcification, which is the beginning of cancer.''

After the inspection, a sampling of the patients' films were sent to the federal agency for review. About half of the samples had issues with contrast, technique and positioning, Sweeten said.

Also, documentation that would verify daily cleaning of the darkroom and the area where mammograms are conducted had not been done "at the desired frequency." Check lists were blank in a four-month period.

Hospital officials would not say how the records ended up missing. They said in a statement that, based on an internal investigation and a review by the American College of Radiology, they thought the quality assurance checks had been conducted.

The statement said the hospital thought the "mammography equipment was functioning properly, and all studies were of appropriate diagnostic quality from an equipment perspective.''

State officials said 92 patients had to be retested, but the hospital said it was missing documentation related to 64 patients who received mammograms between May 25 and Sept. 18, 2007. The period is about a month shorter than the one the health division cited.

Sweeten said in reviewing the hospital records, the lack of records "just stopped'' going back to April 30, 2007, which is how the health division determined the number of patients who needed retesting.

The hospital provided new screenings free of charge to patients who needed them.

The fine comes to $5,000 for each of the 228 violations, Sweeten said.

Under the agreement, Desert Springs agreed to pay the state's health division $228,000. The remaining portion of the fine, $912,000, will be settled over time. To do so, the hospital has agreed to provide community services.

According to the health division, Desert Springs also must outline and detail the duties of a mammographer that follows state and federal regulations, submit quarterly quality control and quality assurance records, and prepare a self-reporting policy that notifies the Radiological Health Section within 10 days of any violations.

Sweeten said this is the first time a facility that provides radiology services has been slapped with such a fine.

However, he said, "it doesn't make anyone bad.''

"In all honesty, Desert Springs has an excellent program,'' he said. "There was a lapse there, and the staff has changed.''

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